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Generated: July 21, 2019

DrugPatentWatch Database Preview

Drug Master Files for: rifamycin

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rifamycin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11291 A II 1/9/1995 LUPIN LTD RIFAMYCIN-S (BULK SUBSTANCE)
11750 I II 11/16/1995 CKD BIO CORP RIFAMYCIN-S
11796 I II 1/22/1996 DIASPA SPA RIFAMYCIN S BULK
22325 A II 12/9/2008 LUPIN LTD RIFAMYCIN O
22907 A II 6/24/2009 OLON SPA RIFAMYCIN SV SODUM SALT
23616 A II 3/8/2010 CKD BIO CORP RIFAMYCIN SODIUM NON-STERILE BULK
25287 I II 9/9/2011 SANOFI AVENTIS SPA RIFAMYCIN SODIUM
DMF No. Status Type Submission Date Holder Subject

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Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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